PROJECT SUMMARY
The Children's Heart Program of South Carolina is a statewide consortium of pediatric cardiologists who provide
pediatric cardiac care for >90% of the 5.1 million residents in the state. The Pediatric Heart Program at MUSC
performs all of the cardiac surgery and interventional cardiac catheterizations for this racially and ethnically
diverse patient population. Clinical outcomes are consistently among the best in the country. MUSC has all the
critical elements to be a successful contributor in the Pediatric Heart Network (PHN): adequate patient volume,
established clinical research infrastructure, a track record of outstanding subject enrollment, and a dedication
to hypothesis driven research. These elements have allowed our site to be a highly successful and
administratively active participant in the PHN and one of only 5 core centers to be continuously funded since its
inception in 2001 The combined resources of patient volume, research infrastructure and dedication have
enabled MUSC to be among the top subject enrollers in the PHN. During this period, we have introduced
numerous trainees and junior faculty to the PHN and mentored them toward successful careers in clinical
investigation. MUSC faculty, nurse practitioners, and ancillary staff have participated as Pls in a wide variety of
multicenter studies, including many NIH-funded trials, analyses of clinical registry data, and industry
sponsored/FDA regulated trials. Our nationally recognized team of investigators have an extensive track record
of extramural funding, national presentations, publications in leading journals, and an extensive network of
diverse collaborators across North America. MUSC faculty also currently direct numerous local clinical research
protocols. In this application, we have submitted a concept proposal for a novel and highly impactful study of
the impact of environmental neurotoxins on early clinical and 18-month neurodevelopmental outcomes of
neonates undergoing cardiac surgery. The aims and hypotheses in this proposal are supported by strong pilot
data generated by our research team in collaboration with external investigators that demonstrate significant
exposure to cyclohexanone, phthalates, and volatile organic compounds in neonates undergoing cardiac
surgery. These exposures occur both in the hospital setting and/or the home environment and have the potential
to explain some of the disparate outcomes observed in this patient population. Our preliminary work has
established the feasibility of the project and the directionality of the findings in terms of impact on patient
outcomes. Given the prior success of PHN centers in enrolling neonates undergoing cardiac surgery in clinical
trials, the project is likely to be completed in a timely fashion and lead to actionable changes in patient care.